mdic 1 december case for quality forum dec 8, 2015 ann ferriter advanced analytics for medical...
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MDIC1
December Case for Quality ForumDec 8, 2015Ann Ferriter
Advanced Analytics for Medical Device Quality
MDIC2
Charter
.
Problem Description
Stakeholders require accurate and complete data to make educated decisions to improve patient access to high quality devices. Three significant challenges to data on medical device quality: 1) Lack of unbiased, relevant and available data2) No consistently applied performance measures and analytical methods3) No secure process or operating model to enable and encourage individual
companies to be fully transparent about product quality.
Objective To provide information and analysis techniques to stakeholders regarding medical device quality and subsequent patient value
Project Scope Included Excluded
Phase 1• Use case definition: Value Analysis Team
and decisions regarding purchasing devices with defined device areas
• Use case development: conversion of data to information, create a set to validate
• Use case pilot and operating model options: identify benefits, identify what it would take to make into a working model
Not all stakeholders will be included in Phase 1 - Phase I will focus on Value Analysis teams.
Future expansions could consider Group Purchasing Organizations, Payers, Healthcare professionals, patients, industry, etc.
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Joanna Engelke
Boston [email protected]
Team members
Steering Committee Sponsor
Project Manager
Project Leader
Rahmat Muhammad
Deloitte & Touche [email protected]
Garth Conrad
Medtronic - [email protected]
Ann Ferriter
Mike Schiller
Danqing Yu
Deloitte & Touche [email protected]
Rachael Marshall
Deloitte & Touche [email protected]
Jacqueline Berretta
J&J - [email protected]
Jeff Kaser
J&J - [email protected]
NathanSoderborg
Melissa Lalomia
Daniel Matlis
George Serafin
Deloitte & Touche [email protected]
Project Leader
Voice of Customer
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VoC: factors that impact purchase decisions
Finance Quality
Patient and clinician satisfaction
Participants identified three factors that impact purchase decisions:
Safety
Effectiveness
Reliability
Patient Experience
Usability
Clinician satisfaction
Availability
Compatibility
Participants confirmed that the proposed quality categories are relevant to the purchase decision but indicated that reliable information is scarce.
Quality categories:
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VoC: willingness to participate in a pilot
All participants are willing to participate in a pilot. However, they require clarity on scope and
requirements for them to share information.
Orlando Health
Providence Health & Services
VA
Baptist Health
Kettering Health Network
UAB Hospital
Quality Categories
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Proposed quality categories: Safety and Effectiveness
Quality category Proposed definition
Safety
Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
Essential Principles of Safety & Performance of Medical DevicesGHTF (SG1-N020R5)June 30, 1999
Effectiveness
A device is clinically effective when it produces the effect intended by the manufacturer relative to the medical conditions … Effectiveness can be thought of as efficacy in the real world clinical environment.
MEDICAL DEVICE REGULATIONS, Global overview and guiding principles
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Additional proposed quality categories
Quality category Proposed definition
ReliabilityDevice will perform satisfactorily for a specified period of time under stated use conditions.
Patient SatisfactionPatient’s perception that a device met or exceeded expectations of usability and outcome.
UsabilityA characteristics of the device or device user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment.
Availability Device is available to fill first request orders.
Compatibility
If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system should be safe and should not impair the specified performance of the devices. Any restrictions on use applying to such combinations should be indicated on the label and/or in the instructions for use.
Essential Principles of Safety and Performance of Medical Devices, FDA, GHTF/SG1/N41R9:2005
Note: These definitions are appropriate for the Analytics pilot. The definitions may evolve as a wider variety of devices bring added complexity to the terms.
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Sources of information about product quality
• Pooled data from Value Analysis Teams
• Registry data
• Clinical trial data
• FDA Adverse Events (MAUDE, SUS)
• FDA R&L, 510(k), PMA
• MedSun Reliability information
• Maintenance Logs
• Hospital Risk Management
• Patient survey information
• Clinician input on usability
• Product specifications and reference to Standards
Pilot Plan
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Activities to pilot launch
Define hypothesis
Define quality categories, metrics and data sources
Identify participants (Value Analysis Committees)
Identify device types for the pilot
Develop dashboards
Draft communications to pilot participants, including roles and responsibilities
Share dashboards with VACs, update based on feedback
Analyze VAC use of information
Finalize recommendations for analytics in medical device quality (include recommendations for operating model)
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Phase 1: Value Analysis Committee Purchasing Hypothesis
If VACs had access to the following information about implanted cardiac and orthopedic device performance:
Safety
Effectiveness
Reliability
Patient experience
Usability
Availability
Compatibility
and they applied predictive analytics to this information, then they would make better informed purchasing decisions to improve patient access to high quality medical devices.
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Device type for the pilot
Low interest Medium High interest
Implants (stents, surgical mesh,
pacemakers, defibrillators, large joints, spine)
Commodities (ventilators, infusion pumps), Neuroembolization
Cardiac catheters
Device areas selected for pilot: Knees and Defibrillators
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Pilot Timeline
Key Activities and Dates
Pilot Activities Dates
Develop dashboards 20 Nov to 8 Jan 16
Identify data to be pooled from hospitals 14 Dec to 4 Jan 16
Draft pilot participant roles and pilot expectations 14 Dec to 4 Jan 16
Share dashboards with Value Analysis Teams and request participation• Device areas: Knees and Defibrillators• Quality criteria: Safety, Effectiveness, Usability, Availability, Reliability and
Compatibility
11 Jan 16
Identify pilot participants• Goal 3 Value Analysis Teams 15 Jan 16
Pilot use of quality information with Value Analysis Teams• Gather feedback on 6 purchasing decisions 30 Jan 16 to 30 Mar 16
Analyze results and draft recommendation 31 Apr 16
Pilot Goal: Determine whether device quality information can be used effectively in Value Analysis Team purchasing decisions
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Illustrative Example
Safety rating
Usability rating
Availability rating
Durability rating
Compatability rating
Customer satisfaction rating
0
0.5
1
Device 1
Device 2
Device 3
Device 4
Status and Timeline
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MDIC Analytics Project status: 8 Dec 2015
Key Deliverables / Milestones
Milestones / Deliverable Dates Percent Complete Status
Prepare and approve charter 25 Sep 15 100%
Form hypothesis 09 Oct 15 100 %
Interview Value Analysis teams10 Nov to 20 Nov 15
100 %
Identify quality characteristics, metrics, data sources
20 Nov 15 100 %
Select device areas 20 Nov 15 100 %
Develop and share pilot proposal at CfQ forum
7 Dec 15 100%
Develop dashboards20 Nov to 8 Jan 16
0%
Identify pilot participants 15 Jan 16 0%
Pilot prep 15 Jan 16 0%
Pilot use of Quality information with Value Analysis Teams
30 Jan 16 to 30 Mar 16
0 %
Analyze results and draft recommendation
31 Apr 16 0%
G Y R= On Time = At Risk = LateC = Complete
Results / Accomplishments
Interviewed Value Analysis Teams including: UAB Hospital, Birmingham AL, Baptist Health, Little Rock, AR, Kettering Health Network, Miamisburg, OH, Orlando Health, Orlando, FL, VA NCPS, Ann Arbor, MI, Providence Health & Services Seattle, WA
Identified sources of information on Safety, Effectiveness, Usability, Availability, Reliability and Compatibility
Selected knees and defibrillators as pilot device areas.
Upcoming Activities
Activity Target Date
Create dashboards with Safety, Effectiveness, Usability, Availability, Reliability and Compatibility information on knees and defibrillators
8 Jan 16
Draft detailed pilot plan 15 Jan 16
Draft advanced analytics agenda for CfQ forum December 8th in Washington, DC
7 Dec 15
Issues/Risks Mitigation
• Aggressive timeline• Need resources to develop
dashboards
• Requesting resources• Request to pool data from Value
Analysis teams
C
C
G
G
G
G
Y
C
C
C
C
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September2015
October 2015
November 2015
December 2015
January 2016
February2016
March 2016
April 2016
Timeline
Project timeline and milestones
Pilot Development
Present project plan and initial voice of customer data at CfQ Forum
Use Case Definition
Conduct Pilot
Gather additional information to refine hypothesis, quality characteristics, and feasibility of obtaining
Develop mock dashboards for agreed-upon quality characteristics
Present pilot plan at CfQ Forum
Pilot kickoff
Finalize quality characteristics, metrics and data sources and propose pilot plan
Develop recommendations for operating model
Form hypothesis (what are we trying to get out of the data?)
Prepare and Approve Charter
Identify three (3) pilot participants
Pilot prep
Questions?